Liège (Belgium) - March 11, 2010, 7:00 AM CET - OncoMethylome Sciences SA
publishes its financial results for the period ended December 31, 2009.
2009 operational highlights:
Starting at the end of 2009, OncoMethylome focused its R&D efforts on four core
areas: colorectal cancer screening, bladder cancer detection, prostate cancer
detection, and pharmacogenomics. In parallel, the company has initiated cost
reductions which are expected to reduce current operating costs by approximately
25%, with the full impact expected in 2011.
1. Pharmacogenomics: In addition to the company's well-known and proprietary
MGMT biomarker, which can predict patient response to standard brain cancer
therapy, the company is developing a portfolio of novel biomarkers for
predicting patient response to major cancer drugs or vaccines. OncoMethylome has
collaborations with several large pharmaceutical companies for the development
of companion diagnostic tests to assist in identifying patients most likely to
respond to new or existing oncology therapies. These collaborations include:
§ Merck KGaA (Cilengitide)
§ Roche (Avastin)
§ Schering Plough (Temodar)
§ GlaxoSmithKline Biologicals (immunotherapeutics)
2. Colorectal cancer: OncoMethylome improved the blood-based colorectal
cancer screening test and published results from further studies in September
2009. The company is in the process of validating its blood-based test on
samples from screening trials involving persons who underwent a colonoscopy. The
test is being developed to serve as a patient-friendly and non-invasive
screening method for detecting colorectal cancer among adults over age 50.
3. Bladder cancer: The company is validating its urine-based assay for the
detection of bladder cancer and for the monitoring of its recurrence and
published excellent results from its studies throughout 2009. The company has
also initiated a program to identify biomarkers that will help to identify
aggressive bladder tumors and optimize therapy selection.
4. Prostate cancer: The company has developed a tissue-based test (already
being sold in North America via LabCorp) and has a urine-based test in
development. In November 2009 Veridex LLC announced that, as part of the general
restructuring of its group, it was discontinuing the development of the prostate
cancer products it had licensed from OncoMethylome. Veridex and OncoMethylome
are now working together to find new partners for the test.
In addition to the above R&D programs, OncoMethylome has cervical cancer
biomarkers that could be used to triage women following positive-HPV or
suspicious Pap test results and the company is working to partner this
application to bring it to market. OncoMethylome has numerous other biomarkers
which could be used for other cancer applications, including lung cancer
detection and prediction of lung cancer recurrence.
2009 financial highlights
The net loss increased in 2009 due to extra spending on clinical trials and to
one-time costs of EUR 2.3 million for a restructuring plan implemented at the
end of 2009.
Key Figures (EUR thousands, except number of shares and per share data):
+---------------------------------------------------+------------+------------+
| As at or for the year ended Dec. 31 | 2009 | 2008 |
+---------------------------------------------------+------------+------------+
| Revenues | 2,548 | 3,024 |
+---------------------------------------------------+------------+------------+
| Operating profit (EBIT) | -14,731 | -11,326 |
+---------------------------------------------------+------------+------------+
| Net loss excluding one-time restructuring charges | -12,020 | -10,192 |
+---------------------------------------------------+------------+------------+
| Net loss | -14,301 | -10,192 |
+---------------------------------------------------+------------+------------+
| Earnings per share, basic (?) | -1.08 | -0.77 |
+---------------------------------------------------+------------+------------+
| Number of outstanding shares | 13,185,614 | 13,161,074 |
+---------------------------------------------------+------------+------------+
| Cash and cash equivalents | 18,032 | 30,601 |
+---------------------------------------------------+------------+------------+
Revenues
Total revenues in 2009 decreased to EUR 2.5 million due to the absence in 2009
of one-time commercial up-front or milestone fees that were present in the
revenues of 2008. The grant-related revenue decreased slightly in 2009 due to
the end of certain subsidized projects in 2008.
Costs and Profitability
Total operating costs increased by EUR 3 million primarily due to (i) one-time
costs of EUR 2.3 million related to the restructuring of activities and the
focus program announced in November 2009 which includes costs related to the
reduction in headcount, the accelerated amortization and depreciation of
non-essential tangible and intangible assets, and a re-organization of internal
R&D activities, and (ii) extra costs in 2009 for the expansion of clinical
trials for the colorectal cancer screening test. The combination of an increase
in operating costs of EUR 3 million, (including the one-time restructuring costs
of EUR 2.3 million), the reduction of interest income of EUR 0.7 million (due
primarily to lower interest rates) and the reduction of revenues of EUR 0.5
million led to a larger loss in 2009.
Cash Position
OncoMethylome's cash and cash equivalents amounted to EUR 18 million at December
31, 2009. The larger operating loss in 2009 led to an increased use of cash for
operations.
Outlook for 2010
* Revenues are expected to remain stable and are expected to include revenues
from (i) the 3 tests already being sold in North America, (ii) new
commercial deals, (iii) personalized medicine collaborations, and (iv)
grants.
* Operating expenses are expected to decrease significantly in 2010 with the
implementation of several cost-cutting initiatives.
* Overall, the company expects to reduce its cash burn in 2010 compared to
2009.
"In 2009, OncoMethylome focused its R&D on product areas which have the highest
likelihood of creating value going forward. This focusing will allow us to
dedicate more resources and attention to a core set of products, thus optimizing
their development and clinical validation, while significantly reducing
operating costs going forward. The OncoMethylome technology continues to be an
excellent technology for cancer applications as demonstrated by our strong
scientific publications in 2009", commented Philip Devine, interim CEO and CFO
of OncoMethylome Sciences.
Other News
Dr. Bob Pinedo has resigned from his position as a Board Director effective as
of the last Board meeting held on March 10, 2010. The Board thanks Dr. Pinedo
for his contributions over the last years.
The net assets to share capital ratio of the non-consolidated and non-IFRS
statutory accounts of the Company has decreased to less than 50%, thus a general
shareholders meeting will be convened in accordance with applicable legal
provisions of Art. 633 of Belgian company law.
Financial statements
To download the consolidated audited financial statements of 2009, click
here: ONCO 2009 Financial Statement
Information for shareholders
The 2009 Annual Report will be available for downloading in the investors
section of www.oncomethylome.com website towards the end of April 2010.
Comments of the Auditor
The financial information included in this press release is derived from the
audited consolidated financial statements under IFRS as adopted by the European
Union. The statutory auditors, BDO Bedrijfsrevisoren - Réviseurs d'Entreprises
CVBA, represented by Bert Kegels, have confirmed that their audit procedures,
which have been substantially completed, have not revealed any material
adjustments which would have to be made to the accounting data included in this
press release as of and for the year ended December 31, 2009. On this basis they
intend to issue an unqualified report including the following explanatory
paragraph : "Although the company has incurred considerable losses which affect
the financial position of the company, the financial statements are prepared in
going concern. This assumption is only justified to the extent that the company
further can rely on the financial support of the shareholders or other financial
sources. Without prejudice to the above unqualified opinion, we draw your
attention to the annual report in which the Board of Directors, according to
Belgian legal requirements, justifies the application of the valuation rules in
going concern. No adjustments were made with respect to valuation or
classification of balance sheet items that would be required in case the company
discontinues its activities."
OncoMethylome Reporting Calendar
May 6, 2010 - First business update
May 28, 2010 - Annual general shareholders' meeting
August 26, 2010 - Half-year 2010 results
November 4, 2010 - Second business update
March 11, 2011 - Full-year 2010 results
About OncoMethylome Sciences
OncoMethylome Sciences (Euronext Brussels: ONCOB; Euronext Amsterdam: ONCOA) is
a molecular diagnostics company developing gene methylation tests to assist
physicians in effectively detecting and treating cancer. Specifically, the
company's tests are designed to help the physician (i) accurately detect cancer
in early stages of cancer development, (ii) predict a patient's response to drug
therapy, and (iii) predict the likelihood of cancer recurrence.
The company collaborates with leading international molecular oncology research
centers, such as The Johns Hopkins University, and has a number of commercial
and collaborative partnerships with LabCorp, Schering-Plough Corp.,
GlaxoSmithKline Biologicals, Millipore Corporation's BioScience Division, Merck
KGaA and Qiagen. OncoMethylome's products are based on methylation technology
invented by Johns Hopkins University (USA).
Established in January 2003, OncoMethylome has offices in Europe and in Durham,
NC (USA).
For more information please contact:
Philip Devine
Tel. +32 4.364.20.70
IR@oncomethylome.com
or visit www.oncomethylome.com
This press release contains forward-looking statements and estimates with
respect to the anticipated future performance of OncoMethylome and the market in
which it operates. Such statements and estimates are based on assumptions and
assessments of known and unknown risks, uncertainties and other factors, which
were deemed reasonable but may not prove to be correct. Actual events are
difficult to predict, may depend upon factors that are beyond the Company's
control, and may turn out to be materially different.
[HUG#1392763]
ONCO 2009 Financial Statement: http://hugin.info/137314/R/1392763/350212.pdf
Press Release: http://hugin.info/137314/R/1392763/350211.pdf